Prior to commencement of clinical studies involving patients,
preclinical testing of new pharmaceutical products is generally conducted
on animals in the laboratory to evaluate the potential efficacy and safety
of the product candidate. The results of these studies are submitted to the
Food and Drug Administration (FDA) as a part of an
Investigational New Drug (IND) application, which must become
effective before clinical testing in humans can begin. Typically, human
clinical evaluation involves a time-consuming and costly three-phase
process. In Phase I, clinical trials are conducted with a small number of
people to assess safety and to evaluate the pattern of drug distribution
and metabolism within the body. In Phase II, clinical trials are conducted
with groups of patients afflicted with a specific disease in order to
determine preliminary efficacy, optimal dosages and expanded evidence of
safety. (In some cases, an initial trial is conducted in diseased patients
to assess both preliminary efficacy and preliminary safety and patterns of
drug metabolism and distribution, in which case it is referred to as a
Phase I/II trial.) In Phase III, large-scale, multi-center, comparative
trials are conducted with patients afflicted with a target disease in order
to provide enough data to demonstrate the efficacy and safety required by
the FDA. The FDA closely monitors the progress of each of the three phases
of clinical testing and may, at its discretion, re-evaluate, alter,
suspend, or terminate the testing based upon the data which have been
accumulated to that point and its assessment of the risk/benefit ratio to
the patient. All adverse events must be reported to the FDA. Monitoring of
all aspects of the study to minimize risks is a continuing process.
The results of the preclinical and clinical testing on non-
biologic drugs and certain diagnostic drugs are submitted to the FDA in the
form of a New Drug Application (NDA) for approval prior to commencement of
commercial sales. In the case of vaccines or gene and cell therapies, the
results of clinical trials are submitted as a Biologics License Application
(BLA). In responding to a NDA or BLA, the FDA may grant marketing approval,
request additional information or refuse to approve if the FDA determines
that the application does not satisfy its regulatory approval criteria.
Product Pipeline
The following chart provides information on the status of the
products we are currently developing.
Clinical Trial Information
We recognize the importance of communicating information about
our current and future clinical trials. Information about enrollment in our
current clinical trials is available on this website. Click here for
further information. Information about future clinical trials will be made
available on
this website when the protocols have been accepted by the
individual
clinical trial sites. For patient inquiries, please send an email
to patients@geron.com, or call 650-
473-7730.
Related Links
For general information about clinical trials, visit the links
below.
For general information about clinical trials that specifically
address cancer, visit the American
Cancer Society
For detailed information about clinical trials that specifically
address cancer, visit the National Cancer Institute Web site at the U.S. National
Institutes of Health (NIH)
